Although no standard definition of research misconduct exists, and new variations are, likely to arise as scientific methods progress, research misconduct generally falls into one of the following areas:
- Mistreatment of research subjects
- Falsification and Fabrication of data
- Piracy and Plagiarism
As a general guide, the term “research misconduct” applies to any action that involves mistreatment of research subjects or purposeful manipulation of the scientific record such that it no longer reflects observed truth. A Joint Consensus Conference on Misconduct in Biomedical Research in October 1999 led to the following broad definition of misconduct: “Behaviour by a researcher, intentional or not, that falls short of good ethical and scientific standard.”1 This section attempts to objectively define research practices that do not meet these subjective standards.
The U.S. Office of Research Integrity defines research misconduct as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”2
The concepts of negligence and deceit are central to the definition of research misconduct. Not every instance of harm to a research subject is necessarily the result of research misconduct. However, editors and others should consider research misconduct in circumstances in which the harm occurs in the setting of, or as a direct result of, research practices that do not meet ethical norms or as a direct result of irresponsible behavior of the investigator. Similarly, not all inaccurate reports of data are the result of misconduct. For example, the Wellcome Trust, Britain’s largest biomedical charity, specifically states that research misconduct does not include honest error or honest differences in the design, execution, interpretation, or judgment in evaluating research methods or results.3 The ORI definition has a similar statement.2 Poor-quality research is not misconduct unless the investigators used poor-quality methods with the intention to deceive or without regard to the harm that might befall subjects.
Researchers have an obligation to the subjects they study. These obligations apply whether the subjects are humans or animals and whether the entire organism or just specimens are being studied. When research involves human subjects or their specimens, failure to adhere to the principles in the Declaration of Helsinki4 and to seek approval from and adhere to the ethical standards of the appropriate institutional or national committee on human experimentation is a serious form of scientific misconduct. For researchers who study animals, failure to follow institutional or national recommendations for the care and use of laboratory animals is also a serious type of research misconduct.
The following are examples of actions that constitute mistreatment of research subjects:
- Failure to obtain approval from an ethical review board before starting the study
- Failure to follow the approved protocol during the conduct of the study
- Absent or inadequate informed consent of human subjects
- Maltreatment of laboratory animals
- Exposure of subjects to physical or psychological harm without informing them of the potential for harm
- Exposure of subjects (or the environment) to harm because research practices or protocols do not meet accepted and/or specified standards
- Failure to maintain confidentiality of human data without specific consent from the subject
Sample correspondence related to this topic is available on the CSE website.5
The International Committee of Medical Journal Editors (ICMJE) addresses this last issue in the Uniform Requirements:6
Patients have a right to privacy that should not be infringed without informed consent. Identifying information, including patients’ names, initials, or hospital numbers, should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that a patient who is identifiable be shown the manuscript to be published.
Perhaps the most blatant and easy to define (although not always easy to detect) form of research misconduct is investigators’ fabrication or falsification of data. Fabrication refers to the invention, recording, or reporting of data. Falsification refers to the alteration of research materials, equipment, protocols, data, or results. Fabrication and falsification are two points along a spectrum, but both are serious forms of misconduct because they result in a scientific record that does not accurately reflect observed truth. Sample correspondence is available on the CSE website.5
Piracy is defined as the unauthorized reproduction or use of ideas, data, or methods from others without adequate permission or acknowledgment. Again, deceit plays a central role in this form of misconduct. The intent of the perpetrator is the untruthful portrayal of the ideas or methods as his or her own.2
Plagiarism is a form of piracy that involves the unauthorized use or close imitation of the language (figures images or tables) and thoughts of others and the representation of them as one’s own original work without permission or acknowledgment by the author of the source of these materials. Plagiarism generally involves the use of materials from others, but can apply to researchers’ duplication of their own previously published reports without acknowledgment (this is sometimes called self-plagiarism or duplicate publication).2 Sample correspondence is available on the CSE website.5
- Joint consensus conference on misconduct in biomedical research: 28th and 29th October 1999: consensus statement. The COPE Report 2000. Available at:http://publicationethics.org/static/2000/2000pdf5.pdf (Accessed March 9, 2012).
- Office of Research Integrity. Definition of Research Misconduct. Available at: http://ori.hhs.gov/misconduct/definition_misconduct.shtml (Accessed March 9, 2012).
- Fraud and misconduct in medical research: causes, investigation and prevention: a report of the Royal College of Physicians. J. R. Coll. Physicians Lond. 1991;25:89–94.
- World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2000;284:3043-3045.
- Council of Science Editors. Sample correspondence. Available at: http://www.www.councilscienceeditors.org/i4a/pages/index.cfm?pageid=3335 (Accessed March 9, 2012).
- International Committee of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. II.E. Privacy and confidentiality. II.E.1. Patients and study participants. Available at: http://www.icmje.org/ethical_5privacy.html (Accessed March 9, 2012).
(Authorship: Christine Laine took the lead in writing this section of the white paper on behalf of the CSE Editorial Policy Committee. Christine Laine revised this section for the 2009 Update. Gene Snyder and Heather Goodell revised this section for the 2012 Update. Members of the Editorial Policy Committee and the CSE Board of Directors reviewed and commented on it. This section was formally approved by the CSE Board Directors on March 30, 2012.)